The group’s complaint stems from the FDA’s inconsistent enforcement of the term “soy milk,” as it warns some companies to drop the word milk on its product labels, while letting other dairy companies continue to use the term.
GFI submitted three separate Freedom of Information Act requests to the FDA in April 2016 and says that it only received a partial response. Its lawsuit now seeks to compel full disclosure of the documents requested.
“The response letter did not identify any documents being withheld or explain the scope of the search conducted, and did not explain FDA's decision not to search the electronic records identified," the lawsuit document stated.
GFI is seeking an order to conduct a reasonable search and promptly disclose all responsive records, as well as costs and fees.
The organization asserts that the FDA has been inconsistent with enforcing its definition on what constitutes as “soy milk,” citing two warning letters requesting that dairy producers should label their products as “soy beverage” or “soy drink.”
One such instance occurred in 2008, when the FDA issued a warning letter to Califorinia-based Lifesoy Inc. The letter stated that the company’s use of “soy milk” is improper because the product does not contain dairy milk. The other warning letter was in 2012.
According to the court document filed by the GFI, the institute's attorney, Nigel Barrella, said "the underlying issue regarding the labeling of soy milk is the interesting part."
"Everyone calls it that (including FDA and [U.S. Department of Agriculture] at times), but then suddenly you see warning letters like these and that creates uncertainty," Barrella wrote in the court document.
Other organizations like the National Milk Producers Federation (NMPF) have been petitioning for FDA to crack down on what it says is the misappropriation of dairy terminology used on non-dairy products for over a decade.
In 2000, NMPF registered a trade complaint about what they referred to as the rapidly expanding misuse of the name of the standardized food term “milk.” The organization’s argument is that the definition clearly goes against the standard identity defined under the USDA Code of Federal Regulations 131.110 (a):
Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in the final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8¼ percent milk solids not fat and not less than 3¼ percent milkfat.
Seeking a resolution
The complaint filed by GFI alleges failure to comply with the 20-working-day statutory deadline for FOIA requests, make reasonable efforts to search for responsive records, and make compliance determination and notification, as well as unlawful withholding of agency records.
The GFI says that the FDA’s lack of consistent regulatory enforcement of the word “soy milk” has ultimately resulted in ongoing consumer confusion and uneven competitive landscape.
"Ultimately we would like to see FDA take a clearer position on this issue, but short of that, we at least hope to find out what has driven FDA's past statements," Barrella added.
FDA spokesperson Lauren Kotwicki said the agency cannot comment on pending litigation.